PATIENT INFORMATION

Read this Patient Information
Leaflet before you receive Makena. There may be new information. This
information does not take the place of talking to your healthcare provider
about your medical condition or treatment.

What is Makena?

Makena is a prescription
hormone medicine (progestin) used in women who are pregnant and who have
delivered a baby too early (preterm) in the past. Makena is used in these women
to help lower the risk of having a preterm baby again.

Makena is for women who:

Are pregnant with one baby

Have had a preterm delivery of
one baby in the past

How well does Makena work?

Makena was studied in women who
were at risk for having a preterm baby because they had previously given birth
to a preterm baby. In the main study, about 37 of 100 women who received Makena
gave birth preterm (before 37 weeks of pregnancy), compared to about 55 of 100
women who did not receive Makena. Another study of Makena is going on to see
whether Makena reduces the number of babies who have serious problems shortly
after birth or who die.

It is not known whether Makena
is safe and effective in women who have other risk factors for preterm birth.

It is not known whether Makena
is safe and effective in women less than 16 years old.

Makena is not intended for use
to stop active preterm labor.

Who should not receive
Makena?

Makena should not be used if
you:

Have now or have had a history of blood clots or other
blood clotting problems

Have now or have had a history
of breast cancer or other hormone-sensitive cancers

Have unusual vaginal bleeding
not related to your current pregnancy

Have yellowing of your skin due to liver problems during your
pregnancy

Have liver problems, including
liver tumors

Have uncontrolled high blood
pressure

What should I tell my
healthcare provider before receiving Makena?

Before you receive Makena, tell
your healthcare provider if you have:

An allergy to
hydroxyprogesterone caproate, castor oil, or any of the other ingredients in
Makena. See the end of this patient leaflet for a complete list of the ingredients in Makena.

Tell your healthcare provider
about all the medicines you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements.

Makena may affect the way other
medicines work, and other medicines may affect how Makena works.

Know the medicines you take.
Keep a list of them to show your healthcare provider and pharmacist when you
get a new medication.

How should I receive Makena?

Do not give yourself Makena injections. A
healthcare professional will give you the Makena injection into your hip area
(upper outer area of the buttocks) once a week (every 7 days).

You will start receiving Makena injections anytime from 16 weeks
and 0 days of your pregnancy up to 20 weeks and 6 days of your pregnancy.

You will continue to receive
Makena injections once weekly until week 37 of your pregnancy or when your baby
is delivered, whichever happens first.

Makena comes in ready-to-use
vials. There are 5 doses of medicine in each vial. Your healthcare professional
should give you only one dose (1 mL) of Makena as prescribed each week.

Makena should be used within
5 weeks after the first use.

It is very important that you do not miss a dose of
Makena and that you continue to receive the medicine once a week. If you miss a
dose, talk to your healthcare provider for specific directions on how to get
back on schedule.

Call your healthcare provider for medical advice about
side effects or pregnancy complications. You may report side effects to FDA at
1-800-FDA1088.

How should I store Makena?

Store Makena at room temperature (59° to 86°F or 15° to
30°C)

Store Makena in the original box to protect it from light

Store the Makena box upright

Makena should be used within 5 weeks after the first use

Keep Makena out of the reach of children

General information about the safe and effective use
of Makena

Medicines are sometimes prescribed for purposes other
than those mentioned in the Patient Information Leaflets. Do not take Makena
for conditions for which it was not prescribed. Do not give Makena to other
people, even if they have the same condition you have. It may harm them.

This leaflet summarizes the most important information
about Makena. If you would like more information, talk with your healthcare
provider. You can ask for information about Makena that is written for
healthcare professionals.

For more information, go to www.makena.com or call
Ther-Rx Corporation Customer Service at the toll free number 1-877-567-7676.

To refill a prescription or to check on prescription
status, call the Makena Care Connection at the toll free number 1-800-847-3418.